MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD LUER-LOK¿ SYRINGE WITH THE BD ECLIPSE¿ SAFETY THIN WALL NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305787
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported that the safety mechanism broke off of the bd luer-lok¿ syringe with the bd eclipse¿ safety thin wall needle during use.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "incident details: when writer was preparing immunizations in clinic, writer opened a bc eclipse 3ml 25g x 1 inch needle.The needle was difficult to attach to the syringe without it being crooked.Once the needle was attached to the syringe, writer needed to pull back the safety that comes in the package in a position where it is up against the cap of the needle.The process of pulling back the safety caused the plastic safety to pop the cap off of the needle onto the floor.Writer did not immediately realize that this had happened and ended up poking the left index finger with the sterile needle.The syringe/needle had to be discarded and a new one opened for immunization use.Having the cap pop off due to moving the safety out of the way has happened several times before.Impact of incident: no harm to patient.Minor injury to staff.Who was affected? health care professional.Response received on 9-aug-2023.When placing the needle on the syringe, did you give it a little twist? when attaching the needle to the syringe, i did give it a little twist to ensure the needle was attached securely to the syringe.The process of attaching the needle to the syringe was difficult as the needle would not go on straight no matter how i tried to attach it.Was there any leakage due to the issue? i have not experienced any leakage due to the issue of having the needle attach to the syringe crookedly.However, having a crooked needle makes immunizing accurately very difficult and it looks unprofessional and scary to the client.Were you able to correct the issue using another needle? in this case i had to use another needle because the needle became contaminated when i poked myself with it.In other cases where the needle attached crookedly, i was unable to remove the crooked needle and replace it with a new one because it is nearly impossible to remove a bd eclipse needle from the syringe once attached to/twisted onto the syringe.There is not enough of a base to the needle for a person to get an adequate grip on the needle in order to remove it.Furthermore, in previous attempts to remove a crooked needle resulted in the safety breaking off, leaving even less surface area to grasp for needle removal.".
Additional Manufacturer Narrative
H.6.Investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.A photo of the defect could assist our quality team in their investigation.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
Event or Problem Description
It was reported that the safety mechanism broke off of the bd luer-lok¿ syringe with the bd eclipse¿ safety thin wall needle during use.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "incident details: when writer was preparing immunizations in clinic, writer opened a bc eclipse 3ml 25g x 1 inch needle.The needle was difficult to attach to the syringe without it being crooked.Once the needle was attached to the syringe, writer needed to pull back the safety that comes in the package in a position where it is up against the cap of the needle.The process of pulling back the safety caused the plastic safety to pop the cap off of the needle onto the floor.Writer did not immediately realize that this had happened and ended up poking the left index finger with the sterile needle.The syringe/needle had to be discarded and a new one opened for immunization use.Having the cap pop off due to moving the safety out of the way has happened several times before.Impact of incident: no harm to patient.Minor injury to staff who was affected? health care professional.Response received on 9-aug-2023.- when placing the needle on the syringe, did you give it a little twist? when attaching the needle to the syringe, i did give it a little twist to ensure the needle was attached securely to the syringe.The process of attaching the needle to the syringe was difficult as the needle would not go on straight no matter how i tried to attach it.- was there any leakage due to the issue? i have not experienced any leakage due to the issue of having the needle attach to the syringe crookedly.However, having a crooked needle makes immunizing accurately very difficult and it looks unprofessional and scary to the client.- were you able to correct the issue using another needle? in this case i had to use another needle because the needle became contaminated when i poked myself with it.In other cases where the needle attached crookedly, i was unable to remove the crooked needle and replace it with a new one because it is nearly impossible to remove a bd eclipse needle from the syringe once attached to/twisted onto the syringe.There is not enough of a base to the needle for a person to get an adequate grip on the needle in order to remove it.Furthermore, in previous attempts to remove a crooked needle resulted in the safety breaking off, leaving even less surface area to grasp for needle removal.".

• Brand Name: BD LUER-LOK¿ SYRINGE WITH THE BD ECLIPSE¿ SAFETY THIN WALL NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17692636
• Report Number: 8041187-2023-00472
• Device Sequence Number: 14966668
• Product Code: FMI
• UDI-Device Identifier: 00382903057870
• UDI-Public: 00382903057870
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 305787
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown